EMRELIS biosimilars — when can they launch?
EMRELIS (TELISOTUZUMAB) · BLA761384 · ABBVIE INC
Where EMRELIS sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for EMRELIS extends to 2037 (11 years from today). Biosimilars cannot be approved by the FDA before this date. Biosimilar developers begin clinical comparability studies 4-6 years before the cliff.
Under the US Biologics Price Competition and Innovation Act (BPCIA), a reference biologic is protected from biosimilar competition for 12 years from FDA approval (with 4 years of data exclusivity preventing 351(k) submissions). Biosimilars enter via the abbreviated 351(k) pathway, which requires comparability — not exact identity — to the reference product.
Key dates for EMRELIS
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by ABBVIE INC) | 2025-05-14 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2029-05-14 | Future |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2037-05-14 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See EMRELIS on Drug Landscape for the full patent picture.
Other ABBVIE INC biologics
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- EMRELIS drug profile — full patent estate, indications, clinical trials
- ABBVIE INC patent portfolio
Not legal advice. BPCIA exclusivity may interact with composition-of-matter patents and patent term extensions — see the full drug profile for the consolidated picture.
Track EMRELIS biosimilar entry
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